Global Regulatory Submissions

In order to obtain the necessary approvals for the various markets it is vital to understand and interpret the regulatory requirements. For this, it requires a combination of knowledge of the local regulatory requirements as well as international standards relating to Biocompatibility, Risk management, Electrical Safety and other product specific standards.

Through the extensive experience in our team and network, we combine an in depth knowledge of international standards with the knowledge of regulatory requirements on the different markets. This combination provides a unique support – to help you get it right.

We can help you with:

• Product classification assessment
• Regulatory assessment for new and/or changed product
• Regulatory strategy
• Regulatory plan
• Regulatory documentation of product
• Compilation or review of registration dossier
• Labeling requirements

Markets

We can support you with regulatory issues, technical documentation and submissions in the following markets:

• EU (CE-marking)
• Canada
• USA
• Asia